1+ months

Director US Quality Control & Analytical Operations R&D

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description


The Director of Quality Control (QC) will lead the QC group for Tevas innovative and Biosimilar products for clinical production and commercial launch from the West Chester site. The holder of this position will report to the Senior Director of Analytical Sciences and Operations, in Biologics R&D- CMC. The individual will lead the management and oversight of the quality control tasks of release and stability of all clinical, PPQ and commercial batches produced by Teva Biologics CMC West Chester, including QC support for the manufacturing site in terms of the environmental monitoring of the facility as well as raw materials testing and release. The leader will collaborate extensively with the Analytical Development groups, Commercial Operations, CMC Development group, Quality Assurance and Regulatory Affairs.  

 

You will oversee and manage well-equipped QC laboratories to provide the required testing in a suitable time frame for the efficient running of all the Teva Biologics programs in CMC Biologics.  You will lead defining the requirements of QC qualifications and validations, and evolve the QC strategy moving forwards with new technologies (as appropriate). This leader will author/review the CMC sections of regulatory filings, address relevant questions from global jurisdictions, and be accountable for the success of pre-approval and routine regulatory inspections of the QC laboratories and practices working with the Compliance and QA teams.   

 

You will be responsible for the appropriate validation and verification of analytical methods used for the QC testing to the appropriate cGMP guidances. You will engage with inspectors from regulatory agencies as well as regular internal audits by the local and global QA groups and is responsible for the strategy towards the maintenance and compliance of the group to all cGMP requirements. This position is also responsible for all method transfers to other QC sites including TGO commercial QC.

 

The holder of this position is required to set goals for and assist in setting development plans for 28+ QC staff. The leader will develop staff, create opportunities for technical and personal development of the team, and create the next generation QC leaders for the company.


Other duties:

  • Lead early and late-stage QC activities for innovative and biosimilar monoclonal antibodies and recombinant proteins 
  • Lead and manage a team of 28+ technical staff responsible for executing QC release, stability testing, In Process Testing, Raw Materials release and Environmental Monitoring of the manufacturing site for biologics programs at various stages of pre-clinical and clinical development
  • Take full responsibility for several QC laboratories with modern state-of-the-art equipment
  • Lead regulatory interactions related to QC
  • Author/review CMC sections of regulatory documents
  • Perform as the primary contact for filings, inspections and other QC CMC deliverables for regulatory approvals
  • Develop and implement robust regulatory strategies related to QC
  • Evaluate and implement new process and analytical technologies focusing on high productivity and high efficiency including, novel separation technologies and automation, as appropriate in a routine QC environment
  • Lead analytical method transfer to clinical or commercial manufacturing sites 
  • Support deviation investigations, process troubleshooting and provide assessments 


 

 

Qualifications

Required Qualifications:

  • Bachelor's degreein Biology, Molecular Biology, Immunology, Biochemistry or Biochemical Engineering or in a related life-sciences or technical field
  • A minimum of 10 years of analytical and laboratory management experience in QC/GMP areas in the biopharmaceutical/biotechnology industry
  • A minimum of 3 years of experience managing a staff

Preferred Qualifications:

  • MS/PhD in Biology, Immunology, Biochemistry or Biochemical Engineering
  • 15+ years of combined experience in QC in biopharmaceutical/biotechnology industry
  • End-to-end understanding of biopharmaceutical product development lifecycle
  • Understanding of digital platforms appropriate for QC operation (e.g., LIMS)
  • Demonstrated success of managing technical teams with diverse background and leading the teams to achieve business objectives, leadership attributes and highest levels of performance standards
  • Relevant publications in peer-reviewed journals and recognition in peer community
  • Experience of developing and implementing new processes with high productivity and increased efficiency
  • Experience of taking primary responsibility for regulatory filings and questions/answers
  • Experience of working with contract laboratories and contract manufacturing organization
  • Experience of statistical data modeling and multivariate analysis tools
  • Familiarity with biological expression systems for recombinant proteins (e.g., bacterial, mammalian etc.) and protein structure and function
  • Experience of leading and managing CMC activities and regulatory filings
  • Hands-on experience with execution of QC/Analytical studies in support of clinical and commercial manufacturing
  • Full understanding of the cGMPs and how these apply to development, scale-up and commercialization of licensed biologics

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

In process of validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-11-23 Expires: 2021-02-04

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Director US Quality Control & Analytical Operations R&D

Teva Pharmaceuticals
West Chester, PA 19380

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